- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344253
Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uveitis in Comparison to Standard Treatment (TEAM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.
Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Heidelberg, Germany, 69120
- Interdisciplinary Uveitis Center, University of Heidelberg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients age 18 and over
- Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year duration
- Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused by macular edema, defined by foveal thickness ≥ 250 µm
- Either primary uveitis or diagnosis of Multiple Sclerosis
- Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of prednisone equivalent without sufficient success
- Previous treatment with other immunosuppressive drugs is facultative
Exclusion Criteria:
- Exclusively anterior uveitis
- Absence of macular edema
- Optic nerve atrophy after neuritis nervi optici
- Peri-or intraocular injection of corticosteroids in the previous 3 months
- Allergies against any interferon
- Depression diagnosed by a psychiatrist
- Hepatic disease
- Infectious Uveitis
- Other auto-immune diseases but MS
- Pregnancy, Lactation
- Lack of reliable contraception
- Patients with metabolic, psychiatric or neoplastic diseases
- Active diseases like asthma, psoriasis or inflammatory bowel disease who have to be treated with corticosteroids
- primary or secondary immune deficiency
- Tuberculosis or other infectious lung diseases
- Hepatitis B or C
- Life vaccination during the trial duration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Interferon beta 3x weekly
|
|
ACTIVE_COMPARATOR: 2
Methotrexate sc 20 mg weekly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
Time Frame: at month 1,3,6 and 12
|
at month 1,3,6 and 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of macular edema (OCT)
Time Frame: at month 1,3,6 and 12
|
at month 1,3,6 and 12
|
Reduction intraocular inflammation (2 step change, SUN classification)
Time Frame: at month 1,3,6 and 12
|
at month 1,3,6 and 12
|
Increase in retinal light sensitivity (fundus controlled perimetry)
Time Frame: at month 1,3 and 12
|
at month 1,3 and 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthias D Becker, MD, PhD,FEBO, Interdisciplinary Uveitis Center, University of Heidelberg
- Principal Investigator: Friederike Mackensen, MD, FEBO, Interdisciplinary Uveitis Center,University of Heidelberg
- Study Director: Regina Max, MD, Interdisciplinary Uveitis Center,University of Heidelberg
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Central Nervous System Infections
- Panuveitis
- Uveal Diseases
- Choroid Diseases
- Macular Degeneration
- Choroiditis
- Uveitis, Posterior
- Multiple Sclerosis
- Sclerosis
- Macular Edema
- Uveitis
- Encephalomyelitis
- Uveitis, Intermediate
- Pars Planitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Interferons
- Methotrexate
- Interferon-beta
Other Study ID Numbers
- EudraCT-Number: 2004-004403-37
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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